Regulatory Affairs Manager / Specialist Animal Health in Brussels

For one of our customer active in the Animal health, based in Belgium (Brussels), we are currently recruiting several profiles experimented in Regulatory Affairs. Positions are available for Senior Associate Level or Manager Level or Associate Director (depending of the experience of the candidate).

In your role, you will facilitate the approval and maintenance of new and in-line veterinary products in EUAfME. In this position, you will actively assemble, submit and manage regulatory submissions to support new product approvals and in-line product maintenance. As expert, you will provide regulatory guidance and strategic direction to project teams and discovery and development groups in the design of development program for candidate veterinary medicines.

Due to your expertise, you will provide regulatory guidance and strategic direction to development groups and in-country Regulatory Affairs Managers in the maintenance of in-line veterinary products.

Some of your key responsibilities are:
- Planning, preparation, submission and support of regulatory applications in EUAfME for designated projects/products, including new Marketing Authorization applications, line extensions, variations, renewals, test permits, generic applications and maximum residue limit applications.
- Act as Departmental expert resource in specified area(s), advising other members of the Department and assisting in the preparation of documentation as appropriate.
- Contribute to the development of regulatory strategies for specified projects, as appropriate, including advising and/or interacting with members of other animal health departments and external bodies.
- Represent the department on global and local project teams, as requested.
- In conjunction with the Artwork Coordinator, coordination and checking of product literature translations and artwork preparation.
- Participation in departmental activities (e.g. process review teams, training, team-building)
- Other specific duties and responsibilities can be added to your responsibilities depending of your expertise.

Profile
The ideal candidate will hold a Master in Sciences (with or without PhD) or be Veterinarian. You have a strong knowledge of the drug or vaccine discovery or development process within a multi-national company and you've a practical experience of the European registration dossier and regulatory processes (new applications and/or product maintenance).
You've the ability to multi-task, and to work to demanding and aggressive timelines whilst remaining focused on strategic goals.
You're flexible and passionate about animal health. Be fluent in English is mandatory.
The company will offer you a very dynamic and nice working environment with a very competitive and attractive salary package. Positions are currently open for immediate start!!

Don't hesitate to send over your application form with CV in English.

This position, Regulatory Affairs Manager / Specialist Animal Health in Brussels, was posted on June 9, 2011. The job is located in Brussels. Since this job has been published, it has been viewed 29 times.